The U.S. Food and Drug Administration (FDA) has approved the first blood test as a primary colorectal cancer (CRC) screening option.
Guardant Health announced in July that its test, called “Shield,” is approved for adults over the age of 45, who are at average risk for colorectal cancer. It is also the first CRC screening blood test eligible for Medicare coverage.
While colonoscopies are still considered the gold standard test for CRC, blood-based tests are significantly more convenient than feces-based tests, making this approval by the FDA a significant upgrade.
“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. said AmirAli Talasaz, Guardant Health co-CEO in a press release. “Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable.”
According to the FDA, CRC is the second-leading cause of cancer fatalities in the U.S., with more than 50,000 deaths each year.
The American Cancer Society estimates that more than 150,000 cases will be diagnosed in 2024 alone. The disease is thought to be highly treatable with early detection.
According to Guardant, more than three out of four individuals who die from the disease are not up to date with their screenings. They emphasize that any approved screening tool can make a significant difference and help save lives.
“Shield,” has been on the U.S. market since 2022 and is currently available by prescription for a self-pay price of $895.
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